Astellas, Vical finalize design for phase-3 cytomegalovirus vaccine trial


SAN DIEGO — Two drug makers have finalized the design of a late-stage clinical trial for a vaccine against a common virus that can cause complications later in life.

Vical and Astellas Pharma announced Monday that they had finalized the general design of a phase-3 trial of TransVax, a vaccine against cytomegalovirus, or CMV, for transplant recipients.

A herpes virus related to the viruses that cause diseases ranging from mononucleosis to chickenpox, CMV infects more than half of all U.S. adults by 40 years old and is more widespread in developing countries. A healthy immune system can protect against the virus, but rarely eliminates the infection, and people with compromised immune systems are at high risk of serious complications. The virus affects 30% to 60% of patients undergoing transplant procedures and can cause transplant rejection, serious illness or death if untreated.

Vical and Astellas will begin recruiting patients who have received hematopoietic stem cell transplants in the second half of this year and will start a phase-2 trial of patients who have received solid organ transplants soon after. Under the two companies' collaboration, Astellas will make a $10 million milestone payment to Vical.

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